CipherOx CRI Tablet— 510(k) K213255

Name: FDA 510(k) clearance K213255
Creator: U.S. Food and Drug Administration
Published: 2022-06-17

Substantially Equivalent

Flashback Technologies, Inc.

FDA 510(k) clearance K213255 for CipherOx CRI Tablet, Substantially Equivalent on 2022-06-17. Applicant: Flashback Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Flashback Technologies, Inc.
Product code: Code PPW
Device class: Class 2
Regulation: 21 CFR 870.2200
Advisory panel: Cardiovascular
Date received: 2021-09-30
Decision date: 2022-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westfield, NJ, US

Download summary PDF View on FDA.gov ↗

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